Influenza
Conditions
Keywords
Influenza
Brief summary
This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in adults.
Detailed description
This randomized, modified double-blind, active-controlled, multi-center trial was conducted in healthy adults (greater than and equal to \[\>=\] 65 years) to assess the safety and immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain from the primary lineage (TIV-HD1; licensed vaccine \[Fluzone® High-Dose\] for the 2017-2018 Northern Hemisphere \[NH\] influenza season) or the B strain from the alternate lineage (TIV-HD2, investigational TIV-HD containing an alternate B strain).
Interventions
BIOLOGICALQIV-HD
0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
BIOLOGICALLicensed TIV-HD1
0.5 mL-dose was administered IM into the upper arm area.
BIOLOGICALInvestigational TIV-HD2
0.5 mL-dose was administered IM into the upper arm area.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).
Intervention model description
QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged \>= 65 years on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2. * Previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on investigator's judgment. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Alcohol or substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion. * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion. * Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial. * Personal or family history of Guillain-Barré syndrome. * Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for \>= 5 years). * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0°C \[\>= 100.4°F\]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event had subsided.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 28 post-vaccination | GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. |
| Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 28 post-vaccination | Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (\<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination. |
| Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 28 post-vaccination | Seroconversion was defined as either a HAI titer \<10 (1/dilution) at Day 0 and post-injection titer \>=40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. |
| Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer \>=40 (1/dilution) at Day 0 and Day 28. |
| Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). |
| GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 0 (pre-vaccination) and Day 28 post-vaccination | GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination. |
| Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | Day 0, Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer \>= 1:10 (1/dilution) at Day 0 and Day 28. |
| Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value. |
| Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Within 7 days after vaccination | Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: \>100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: \>=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. |
| Number of Participants With Immediate Adverse Event (AEs) | Within 30 minutes after vaccination | Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
| Number of Participant With Unsolicited Adverse Event (AE) | Within 28 days after vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
| Number of Participant With Serious Adverse Event | Up to 6 months after vaccination | An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event. |
| Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | Day 0, Day 28 | Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers \>=20 (1/dilution), \>=40 (1/dilution), \>=80 (1/dilution) at Day 0 and Day 28. |
| GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Day 28 post-vaccination | Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain. |
Countries
United States
Participant flow
Recruitment details
Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.
Pre-assignment details
A total of 2670 participants were randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0. | 1,777 |
| High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0. | 443 |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0. | 450 |
| Total | 2,670 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 0 |
| Overall Study | Lost to Follow-up | 3 | 0 | 0 |
| Overall Study | Protocol Deviation | 4 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1) | High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Total |
|---|---|---|---|---|
| Age, Continuous | 72.9 years STANDARD_DEVIATION 5.63 | 72.8 years STANDARD_DEVIATION 5.79 | 73.2 years STANDARD_DEVIATION 5.49 | 73.0 years STANDARD_DEVIATION 5.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 2 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 2 Participants | 3 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 123 Participants | 41 Participants | 35 Participants | 199 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 1 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) White | 1618 Participants | 395 Participants | 402 Participants | 2415 Participants |
| Sex: Female, Male Female | 1027 Participants | 268 Participants | 252 Participants | 1547 Participants |
| Sex: Female, Male Male | 750 Participants | 175 Participants | 198 Participants | 1123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 1,777 | 2 / 443 | 0 / 450 |
| other Total, other adverse events | 935 / 1,777 | 234 / 443 | 206 / 450 |
| serious Total, serious adverse events | 80 / 1,777 | 29 / 443 | 19 / 450 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time frame: Day 28 post-vaccination
Population: Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine \& had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 312 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 516 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 578 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 563 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 387 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 476 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 588 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 580 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 362 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 600 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 594 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) | Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 374 titers (1/dilution) |
Comparison: B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [0.958, 1.224]
Comparison: B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [0.881, 1.129]
Comparison: A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [0.744, 0.932]
Comparison: A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [0.842, 1.066]
Primary
Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (\<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (\>=) 40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 50.4 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 36.5 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 46.6 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 49.8 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 56.2 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 39.0 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 52.9 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 48.4 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 51.2 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 48.1 percentage of participants |
| High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2 | 50.5 percentage of participants |
| High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled) | Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1 | 53.7 percentage of participants |
Comparison: B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.95% CI: [-7.66, 2.7]
Comparison: B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.95% CI: [-7.04, 3.53]
Comparison: A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.95% CI: [-4.83, 3.42]
Comparison: A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.95% CI: [-7.37, 0.86]
Secondary
Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine\& had post-vaccination blood sample HAI result for at least 1 strain\& were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed'=participants with available data for each category
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 412 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 497 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 458 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 0 | 156 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 2229 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 1404 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 1288 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 28 | 546 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 452 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 1114 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 0 | 155 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 2050 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 1327 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 427 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 536 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 28 | 259 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 430 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 593 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 416 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 0 | 192 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 590 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 1301 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 1686 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day 28 | 494 titers (1/dilution) |
Secondary
GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 4.38 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 4.65 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 3.17 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 3.82 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 1.86 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 5.57 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 3.35 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 4.82 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 3.82 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 4.94 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 1.65 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 4.76 ratio |
Secondary
GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 5.40 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 2.83 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 2.81 ratio |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 3.51 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 1.66 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 5.05 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 2.47 ratio |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 2.50 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata: Day28/Day 0 | 2.58 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day28/Day 0 | 2.19 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day28/Day 0 | 1.37 ratio |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day28/Day 0 | 4.06 ratio |
Secondary
GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 515 titers (1/dilution) |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 573 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 280 titers (1/dilution) |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 253 titers (1/dilution) |
Comparison: The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [1.804, 2.315]
Comparison: The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.95% CI: [1.802, 2.288]
Secondary
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: \>100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: \>=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Grade 3 | 3 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Any Grade | 95 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Grade 3 | 12 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Any Grade | 7 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Grade 3 | 16 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Any | 86 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Grade 3 | 11 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Any Grade | 402 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Grade 3 | 5 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Grade 3 | 11 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Grade 3 | 13 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Grade 3 | 0 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Any Grade | 233 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Any | 66 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Any | 110 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Any | 23 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Grade 3 | 3 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Any Grade | 254 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Grade 3 | 5 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Any | 731 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Grade 3 | 0 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Any Grade | 3 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Any Grade | 63 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Grade 3 | 2 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Any | 17 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Grade 3 | 0 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Any | 172 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Any | 23 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Grade 3 | 0 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Any Grade | 52 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Grade 3 | 3 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Any Grade | 80 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Grade 3 | 3 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Any Grade | 20 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Grade 3 | 3 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Any | 6 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Any | 30 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Grade 3 | 3 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Any | 152 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Any Grade | 22 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Erythema: Any | 21 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Shivering: Grade 3 | 0 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Induration: Any | 14 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Fever: Any Grade | 5 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Any | 4 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Grade 3 | 2 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Any Grade | 67 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Headache: Any Grade | 58 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Malaise: Grade 3 | 1 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Swelling: Any | 19 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Bruising: Grade 3 | 0 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Myalgia: Any Grade | 88 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | Injection Site Pain: Grade 3 | 1 Participants |
Secondary
Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer \>= 1:10 (1/dilution) at Day 0 and Day 28.
Time frame: Day 0, Day 28
Population: Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 0 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 0 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: Titer >= 1:10: Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: Titer >= 1:10: Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: Titer >= 1:10: Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: Titer >= 1:10: Day 28 | 99 Participants |
Secondary
Number of Participants With Immediate Adverse Event (AEs)
Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: Within 30 minutes after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Immediate Adverse Event (AEs) | 5 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Immediate Adverse Event (AEs) | 0 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Immediate Adverse Event (AEs) | 2 Participants |
Secondary
Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers \>=20 (1/dilution), \>=40 (1/dilution), \>=80 (1/dilution) at Day 0 and Day 28.
Time frame: Day 0, Day 28
Population: Analysis was performed on expanded immunogenicity subset.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 0 | 101 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 0 | 95 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 0 | 89 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 0 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 0 | 99 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 0 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 0 | 97 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 0 | 97 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 0 | 91 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 0 | 98 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 0 | 91 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 0 | 75 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 28 | 101 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 0 | 96 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 0 | 93 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 0 | 89 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 0 | 98 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 28 | 101 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 28 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 0 | 75 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 0 | 96 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 28 | 83 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 0 | 100 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 28 | 102 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 0 | 93 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 0 | 87 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=40 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 0 | 74 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=40 (1/dil): Day 28 | 97 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=80 (1/dil): Day 28 | 97 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=80 (1/dil): Day 28 | 91 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=20 (1/dil): Day 0 | 98 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=40 (1/dil): Day 0 | 91 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H1N1: >=80 (1/dil): Day 0 | 84 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Yamagata: >=20 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=20 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 28 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=40 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | A/H3N2: >=80 (1/dil): Day 0 | 98 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 0 | 99 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28 | B Victoria: >=20 (1/dil): Day 28 | 99 Participants |
Secondary
Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.
Time frame: Day 28
Population: Analysis was performed on expanded immunogenicity subset. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H3N2 | 27 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Yamagata | 36 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Victoria | 28 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Victoria | 52 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H1N1 | 74 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Yamagata | 65 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H3N2 | 52 Participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H1N1 | 43 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Victoria | 51 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H1N1 | 71 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H1N1 | 50 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H3N2 | 48 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H3N2 | 24 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Victoria | 23 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Yamagata | 31 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Yamagata | 11 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Victoria | 8 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H1N1 | 41 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: B Yamagata | 29 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Yamagata | 55 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H1N1 | 64 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: B Victoria | 24 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 4-Fold Rise: A/H3N2 | 23 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28 | Participants With 2-Fold Rise: A/H3N2 | 42 Participants |
Secondary
Number of Participant With Serious Adverse Event
An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.
Time frame: Up to 6 months after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participant With Serious Adverse Event | 80 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participant With Serious Adverse Event | 29 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participant With Serious Adverse Event | 19 Participants |
Secondary
Number of Participant With Unsolicited Adverse Event (AE)
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: Within 28 days after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Number of Participant With Unsolicited Adverse Event (AE) | 292 Participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Number of Participant With Unsolicited Adverse Event (AE) | 79 Participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Number of Participant With Unsolicited Adverse Event (AE) | 68 Participants |
Secondary
Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Seroconversion was defined as either a HAI titer \<10 (1/dilution) at Day 0 and post-injection titer \>=40 (1/dilution) at Day 28, or HAI titer \>=10 (1/dilution) at Day 0 and a \>=4-fold increase in HAI titer (1/dilution) at Day 28.
Time frame: Day 28 post-vaccination
Population: Analysis was performed on FAS. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 36.3 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 46.7 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata | 17.4 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria | 15.5 percentage of participants |
Comparison: B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.95% CI: [24.78, 33.29]
Comparison: B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.95% CI: [16.5, 24.61]
Secondary
Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer \>=40 (1/dilution) at Day 0 and Day 28.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 69.4 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 77.4 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 88.9 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 0 | 89.6 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 95.1 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 96.9 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 99.0 percentage of participants |
| High-Dose Quadrivalent Influenza Vaccine (QIV-HD) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 28 | 99.3 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 87.9 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 99.1 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 0 | 88.1 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 96.7 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 96.9 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 67.9 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 78.1 percentage of participants |
| High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 28 | 96.7 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 0 | 88.8 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 0 | 77.8 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 0 | 70.1 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 0 | 90.9 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Victoria: Day 28 | 96.5 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H3N2: Day 28 | 96.7 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | A/H1N1: Day 28 | 95.6 percentage of participants |
| High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2) | Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine | B Yamagata : Day 28 | 99.1 percentage of participants |